NIH and the Food and Drug Administration on Feb. 24 held a joint meeting in Lipsett Amphitheater
to announce a new level of partnership. The agencies will establish a six-member Joint NIH-FDA Leadership Council to help ensure that regulatory considerations form an integral part of biomedical research planning and that the latest science is integrated into the regulatory
review process.

In addition, NIH and FDA will jointly issue a Request for Applications, making $6.75 million
available over 3 years for work in regulatory
science.

“We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years,” said HHS Secretary
Kathleen Sebelius. “However, much more can be done to speed the progress from new scientific
discoveries to treatments for patients. Collaboration between NIH and FDA, including
support for regulatory science, will go a long way to foster access to the safest and most effective therapies for the American people.”

A packed Lipsett Amphitheater,
where questions from constituents were addressed, provided the venue for the announcement.

“The FDA plays an essential and unique role in how therapies are evaluated,” said FDA commissioner
Dr. Margaret Hamburg, who will co-chair the Leadership Council with NIH director Dr. Francis Collins. “We are the bridge between biomedical research discoveries and new medical
products. We now have a special opportunity—
and responsibility—to harness advances
in science and technology to support our efforts. We are working in collaboration with the best minds and research institutions available,
so that we can better develop and utilize new tools, standards and approaches needed to properly assess the safety, effectiveness and quality of products currently in development or already on the market.”

Collins said, “This collaboration is the first of its kind and will use the NIH’s breadth of experience as a leader in biomedical sciences to help make the translation of biomedical discoveries into effective treatments as seamless as possible.”

The agencies will hold a public meeting in the spring to solicit input on how they can work better
together.